Pharmacokinetics [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]

Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).

Secondary Outcome Measures:

Disease parameters [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]

After completion of study treatment, patients are followed up periodically for 3 years.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Eligibility Criteria

Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable

Prostate cancer deemed to be hormone refractory or androgen independent within the past 12 months

Evidence of bony metastasis

Either be receiving bisphosphonate therapy or have received a bisphosphonate within the last 18 months. Participants who are on not on bisphosphonate therapy nor have received it within the last 18 months should currently be on Denosumab therapy. All other anti-cancer therapies are allowed.

Age >18 years

ECOG performance status 0-2 (Karnofsky >50%).

Life expectancy of 6 months or greater.

Investigators are encouraged to follow good medical practice to assure that all participants have adequate hematologic, hepatic, and renal function.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants will be excluded who have experienced a severe skeletal related event (SRE)within the past 3 months. For this study, an SRE consists of any of the following: palliative radiotherapy to bone, pathologic fractures, spinal cord compression, hypercalcemia of malignancy, and surgery to bone to treat or prevent a fracture.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918645